TAVIPhase 3OCCTAVI-INCT01759563
Oxygenation of the Cerebrum and Cooling During TAVI - Part I
A Phase 3 study testing nasopharyngeal targeted brain cooling in people with TAVI and Targeted Brain Cooling, run by Hasselt University at 1 site in Belgium.
Trial summary
Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without delaying the procedure of valve… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TAVI, Targeted Brain Cooling, Neuroprotection
- What is being tested?
- nasopharyngeal targeted brain cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pts eligible for TAVI interventions
Who cannot join
- urgent intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation
Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without delaying the procedure of valve implantation.
Read the detailed description
OCCTAVI-I Protocol
6 patients selected for Transcutaneous Aortic Valve Implantation (TAVI)-procedure will be subjected to intra-operative transnasal cooling (RhinoChill) ; cooling will be started after induction of anesthesia until tympanic temperature achieves 34° (cooling will be continued until 33°C of tympanic temperature, below 33°C active cooling will be stopped)
No intra-aortic catheter will be inserted before tympanic temperature reaches 34°
The aim of this study is to test the safety (as referring to routinely used neuromonitoring : ForeSight cerebral tissue oxygen saturation (SctO2) monitoring; and as referring to cardiovascular stability : blood pressure \& heartrate) and feasibility (as referring to temperature characteristics) of brain cooling during TAVI (cerebral (or tympanic) cooling rate, differential tympanic-rectal cooling rate, rectal cooling rate, time needed to obtain tympanic temperature below 34°)
Patients will be monitored with FORE-SIGHT cerebral oximeter (regional cerebral oxygen saturation, sensors placed on patient's forehead) and BIS VISTA (bilateral continuousEEG).
Tympanic temperature will be measured every 5 minutes while oesophageal and blood temperature will be continuously measured.
- Neuromonitoring (Fore-Sight, Bispectral Index (BIS) Vista) will be started before induction of anesthesia and cooling
- Transnasal cooling will be started after induction of anesthesia until a target tympanic temperature of 34°C
- Core temperature will not be monitored by esophageal (caveat interaction TEE probe), but by rectal and blood temperature
- TAVI-procedure will be started at a tympanic temperature of 34°C
- Arterial CO2 tension (PaCO2) will be checked every 30 minutes intra-operatively (target=normocapnia) by arterial blood gas analysis to maintain strict normocapnia
- and the end of the TAVI-procedure, patient will be rewarmed at a max rate of 0.8°/h by total body bair hugger
- when patient reaches tympanic and systemic (rectal) temperature of 35.5°C, extubation can be performed
- Conditions
- TAVI, Targeted Brain Cooling, Neuroprotection
- Being tested
- nasopharyngeal targeted brain cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal targeted brain coolingDevice
Also called RhinoChill Device, BeneChill company
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | Not described Receives: Device: nasopharyngeal targeted brain cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique.
By the use of nasopharyngeal cooling, brain temperature will be decreased. Time to brain temperature below 34° will be recorded. Local side effects could occur due to the use of this specific nasopharyngeal cooling technique and systemic side effects (especially cardiovascular) could occur due to the initiation of hypothermia
Measured: Day1: start of cooling until brain temperature above 35.5°C
Secondary outcomes (1)
changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling
NIRS (or Near-infrared Spectroscopy) enables non-invasive monitoring of cerebral oxygen saturation during TAVI procedure and during the installation of targeted brain cooling. NIRS will be used as cerebral monitoring technique during this study protocol
Measured: Day 1: start of cooling until brain temperature above 35.5°C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TAVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Cathy De Deyne, Ziekenhuis Oost-Limburg
- Investigators
- Cathy De Deyne, Md, PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759563
- Sponsor's protocol ID
- OCCTAVI-I
- Other IDs
- COBRA Research Group
- Acronym
- OCCTAVI-I
- Status last verified
- Jan 2013
- First submitted
- 27 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
PubMed 20679548
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Nasopharyngeal Cooling (RhinoChill Device) During Transcutaneous Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT01759563
- Acronym / sponsor ID
- OCCTAVI-I / OCCTAVI-I
- Conditions
- TAVI, Targeted Brain Cooling, Neuroprotection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without delaying the procedure of valve implantation.
Detailed description
OCCTAVI-I Protocol
6 patients selected for Transcutaneous Aortic Valve Implantation (TAVI)-procedure will be subjected to intra-operative transnasal cooling (RhinoChill) ; cooling will be started after induction of anesthesia until tympanic temperature achieves 34° (cooling will be continued until 33°C of tympanic temperature, below 33°C active cooling will be stopped)
No intra-aortic catheter will be inserted before tympanic temperature reaches 34°
The aim of this study is to test the safety (as referring to routinely used neuromonitoring : ForeSight cerebral tissue oxygen saturation (SctO2) monitoring; and as referring to cardiovascular stability : blood pressure \& heartrate) and feasibility (as referring to temperature characteristics) of brain cooling during TAVI (cerebral (or tympanic) cooling rate, differential tympanic-rectal cooling rate, rectal cooling rate, time needed to obtain tympanic temperature below 34°)
Patients will be monitored with FORE-SIGHT cerebral oximeter (regional cerebral oxygen saturation, sensors placed on patient's forehead) and BIS VISTA (bilateral continuousEEG).
Tympanic temperature will be measured every 5 minutes while oesophageal and blood temperature will be continuously measured.
- Neuromonitoring (Fore-Sight, Bispectral Index (BIS) Vista) will be started before induction of anesthesia and cooling
- Transnasal cooling will be started after induction of anesthesia until a target tympanic temperature of 34°C
- Core temperature will not be monitored by esophageal (caveat interaction TEE probe), but by rectal and blood temperature
- TAVI-procedure will be started at a tympanic temperature of 34°C
- Arterial CO2 tension (PaCO2) will be checked every 30 minutes intra-operatively (target=normocapnia) by arterial blood gas analysis to maintain strict normocapnia
- and the end of the TAVI-procedure, patient will be rewarmed at a max rate of 0.8°/h by total body bair hugger
- when patient reaches tympanic and systemic (rectal) temperature of 35.5°C, extubation can be performed
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Device: nasopharyngeal targeted brain cooling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pts eligible for TAVI interventions
Key exclusion criteria (1 listed)
- urgent intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal targeted brain coolingAlso: RhinoChill Device, BeneChill company | Device | single arm study |
Primary outcome
Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique.
Time frame: Day1: start of cooling until brain temperature above 35.5°C
By the use of nasopharyngeal cooling, brain temperature will be decreased. Time to brain temperature below 34° will be recorded. Local side effects could occur due to the use of this specific nasopharyngeal cooling technique and systemic side effects (especially cardiovascular) could occur due to the initiation of hypothermia
1 secondary outcome
changes in cerebral oxygenation (NIRS Fore-Sight technology) induced by targeted brain cooling
Time frame: Day 1: start of cooling until brain temperature above 35.5°C
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Background: PubMed 20679548Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy De Deyne, Md, PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nasopharyngeal targeted brain cooling in people with TAVI and Targeted Brain Cooling, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is the brain temperature obtained after initiation of nasopharyngeal cooling. Safety-outcome includes local or systemic side-effects of used cooling technique. (time frame: Day1: start of cooling until brain temperature above 35.5°C). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.